Clinical Operations Lead

Vigeo Therapeutics, Inc., a venture capital-backed biotechnology company based in Cambridge MA developing novel anti-tumor therapeutics, is looking for an outstanding Clinical Operations Lead to build and manage our clinical operations function. Reporting to the Vice President of Program Management and Operations, this individual will help lead ongoing clinical activities for a first-in-human program as well as initiate operational planning for multiple clinical trials currently under development. With the support of the Vigeo team, this individual will also build out the Clinical Operations group to support our clinical trial portfolio.

Essential Functions:

The Clinical Operations Lead will oversee clinical trial execution to ensure compliance with regulatory requirements, adequacy of data acquisition and management, and timely completion of clinical studies.

 The Clinical Operations Lead will be expected to:

• Implement all logistics associated with execution of clinical studies and provide daily oversight of operations
• Contribute to design and review of clinical trial documents and plans, regulatory submissions, and reports
• Contribute to identification, evaluation and selection of investigators, sites, and vendors
• Serve as the primary point of contact and provide guidance for project specific CROs and vendors
• Expedite problem identification and resolution and ensure timely completion of clinical trials
• Review and provide guidance on monitoring visit reports from CROs as needed to ensure applicable regulatory and protocol compliance, issue resolution, and quality site management and reporting
• Ensure eTMF is current throughout the conduct of assigned clinical trials
• Lead strategies for patient recruitment and retention in clinical trials
• Monitor, communicate, and manage budgets for clinical trials

Travel is required (approximately 30%)

Qualifications:

• Bachelor's degree required
• 6-8+ years of clinical trial management experience in oncology
• Early-phase clinical trial experience, including IND submission, site start-up activities, and ongoing trial management
• Strong vendor management experience
• Deep knowledge of GCP, ICH, and FDA guidelines
• Experience in CSR preparation and Health Authority interactions
• Experience selecting, managing, troubleshooting, and negotiating with (CRO) vendors
• Computer proficiency (Microsoft Office suite, Microsoft Project, and expertise with current electronic patient-tracking systems)  
• Strong project management and interpersonal skills
• Excellent written and oral communication skills

Our Ideal Candidate:

• Has a proven track record of taking clinical programs from first-in-human to clinical proof-of-concept and beyond
• Is a strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment
• Is a motivated leader with a passion for bringing new treatments to patients
• Is excited by a lean and changing organization, and by the opportunity to "wear multiple hats"
• Enjoys a transparent, outcome-oriented, respectful, and innovative environment

Interested joining the Vigeo Therapeutics team? Please submit Resume/CV and cover letter.